국가: 유럽 연합
언어: 몰타어
출처: EMA (European Medicines Agency)
azathioprine
Nova Laboratories Ireland Limited
L04AX01
azathioprine
Immunosoppressanti
Rifjut ta 'Graft
Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidBehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm IgG antibodieschronic refractory idiopathic thrombocytopenic purpuraJayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.
Revision: 1
Awtorizzat
2021-06-21
29 B. FULJETT TA’ TAGĦRIF 30 FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT JAYEMPI 10 MG/ML SOSPENSJONI ORALI azathioprine AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA PERESS LI FIH INFORMAZZJONI IMPORTANTI GĦALIK. - Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah. - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar, jew lill-infermier tiegħek. - Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha lil persuni oħra. Tista’ tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard bħal tiegħek. - Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar jew lill-infermier tiegħek. Dan jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara sezzjoni 4. F’DAN IL-FULJETT 1. X’inhu Jayempi u għalxiex jintuża 2. X’għandek tkun taf qabel ma tieħu Jayempi 3. Kif għandek tieħu Jayempi 4. Effetti sekondarji possibbli 5. Kif taħżen Jayempi 6. Kontenut tal-pakkett u informazzjoni oħra 1. X’INHU JAYEMPI U GĦALXIEX JINTUŻA Jayempi 10 mg/ml sospensjoni orali fih is-sustanza attiva azathioprine. Dan jagħmel parti minn grupp ta’ mediċini msejħa immunosuppressanti. Dawn il-mediċini jnaqqsu l-attività tas-sistema immuni tiegħek (id-difiżi tal-ġisem). Jayempi jintuża biex: • Jipprevjeni lill-ġisem tiegħek milli jirrifjuta trapjant ta’ organu. Jayempi normalment jintuża flimkien ma’ immunosoppressivi oħra għal dan il-għan • Jittratta xi mard fuq perjodu ta’ żmien twil fejn is-sistema immuni tkun qed tirreaġixxi kontra l- ġisem tiegħek. Jayempi normalment jintuża flimkien ma’ sterojdi jew mediċini antiinfjammatorji oħra. Dan il-mard jinkludi: - Artrite rewmatika severa jew poliartrite kronika (infjammazzjoni kronika fit-tul tal-ġogi multipli) li ma jistgħux jiġu kkontrollati b’mediċini oħra - Mard infjammatorju kroniku tal-musrana (mard tal-imsaren bħall-marda ta’ Crohn u kolite ulċerattiva) - Epatite kronika (epatite awtoimmuni), marda 전체 문서 읽기
1 ANNESS I SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT 2 1. ISEM IL-PRODOTT MEDIĊINALI Jayempi 10 mg/ml sospensjoni orali 2. GĦAMLA KWALITATTIVA U KWANTITATTIVA Kull ml ta’ sospensjoni fih 10 mg azathioprine. Eċċipjenti b’effett magħruf Is-sospensjoni fiha 1.5 mg sodium benzoate (E211) f’kull ml. Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1. 3. GĦAMLA FARMAĊEWTIKA Sospensjoni orali Sospensjoni viskuża safra 4. TAGĦRIF KLINIKU 4.1 INDIKAZZJONIJIET TERAPEWTIĊI Jayempi huwa indikat flimkien ma’ sustanzi immunosoppressivi oħra għall-profilassi ta’ rifjut ta’ trapjant f’pazjenti li jkunu qed jirċievu trapjanti alloġeniċi tal-kliewi, tal-fwied, tal-qalb, tal-pulmun jew tal-frixa. Azathioprine huwa indikat f’korsijiet immunosoppressivi bħala żieda ma’ sustanzi immunosuppressivi li jiffurmaw il-bażi tat-trattament (immunosoppressjoni ta’ bażi). Jayempi jintuża bħala antimetabolit immunosuppressanti jew waħdu jew, b’mod aktar komuni, flimkien ma’ sustanzi oħra (normalment kortikosterojdi) u/jew proċeduri li jinfluwenzaw ir-rispons immuni. Jayempi huwa indikat f’pazjenti li ma jittollerawx il-glukokortikosterojdi jew jekk ir-rispons terapewtiku ma jkunx adegwat minkejja t-trattament b’dożi għoljin ta’ glukokortikosterojdi, fil-mard li ġej: - artrite rewmatika attiva severa (poliartrite kronika) li ma tistax tinżamm taħt kontroll b’sustanzi anqas tossiċi (prodotti mediċinali antirewmatiċi li jimmodifikaw il-marda – DMARDs) - epatite awtoimmuni - lupus eritematuż sistemiku - dermatomijożite - poliarterite nodosa - pemfigus vulgaris u pemfigojd bulluż - il-marda ta’ Behçet - anemija emolitika awtoimmuni refrattarja, ikkawżata minn antikorpi sħan tal-IgG - purpura tromboċitopenika idjopatika refrattarja kronika Jayempi jintuża għat-trattament ta’ forom moderatament severi sa severi ta’ marda infjammatorja tal- imsaren (IBD) kronika (il-marda ta’ Crohn jew kolite ulċerattiva) f’pazjenti li fihom hija meħtieġa terapija bil-glukokorti 전체 문서 읽기